MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZA LM/RL PMA; KNEE PROSTHESIS

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 11/28/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Unique identifier (udi) number: (b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00040, 3002806535-2019-00042.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent initial left knee arthroplasty.Subsequently, the patient was revised due to unknown reasons.

Event Description

It was reported that the patient underwent initial left knee arthroplasty.Subsequently, the patient was revised due to tibial component loosening.The surgeon reported that the cement/bone interface failed.

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent initial left knee arthroplasty.Subsequently, the patient was revised due to tibial component loosening.The surgeon reported that the cement/bone interface failed.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Visual inspection confirmed the reported event.Visual inspection of the returned femoral component indicated uneven cement mantle thickness and limited integration of the bone cement with bone whereas the tibial component displayed evidence of good integration, mainly around the keel.Extruded bone cement that was not removed during the surgery was observed posteriorly from both the tibial tray and femoral component.Pitting and scratches visible on the bearing, femoral and tibial components indicate that third body particles may have been present within the joint space.Sub-optimal cementing technique was identified on both tibial and femoral component, however, the loosening of the tibial component could not be confirmed and the exact cause of the revision could not be determined from the information provided in the complaint.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: OXF UNI TIB TRAY SZA LM/RL PMA
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8235371
• MDR Text Key: 132764344
• Report Number: 3002806535-2019-00041
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 154718
• Device Lot Number: 454430
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR